Incorporates

Regulatory Information Management & IDMP Solutions Solutions

by Susan Metz, Principal Consultant IDMP, PAREXEL International, and Member of the IDMP Task Force

On 19th February 2016, the EU ISO IDMP Task Force had a face-to-face meeting. The following are some key takeaways from the meeting:

The Task Force will be renamed to “SPOR Task Force” as there is no legal basis to refer to IDMP as a Task Force.

SPOR is what the EMA calls their Master Data Management System (Substances, Products, Organisations, and Referentials).

The scope of Task Force will now include Veterinary products.

At this time, Veterinary product submissions have not been moved into Iteration 1. The inclusion of Veterinary products is primarily to understand what is needed for Organisations and Referentials.

Swissmedic has become part of the Task Force as observers. At this time they will not play an active role, but their interest and involvement is very much welcome.

At the previous day’s HMA meeting, it was agreed that the priority for 2016 is implementation of Referentials and Organisations.

Referentials and Organisations are the building blocks needed for Substances and Products.

Analysis for Substances and Products will continue moving forward, but implementation/building activities within the EMA are not targeted to begin until 2017.

Referentials (i.e. Controlled Vocabularies)

The RMS system is targeted for go live in September 2016, starting with vocabularies for Route of Administration, Dosage Forms, Units of Measure, and Containers

The EMA will act as a Hub for vocabularies providing, a “one stop shop” for IDMP vocabularies with web access and via the use of an API.

External vocabularies like MedDRA or those controlled by the WHO are not included as part of the Hub vocabularies

User Acceptance Testing (UAT) is targeted for the July/August 2016 time frame.

All organisations that would use the vocabularies (i.e. Industry, NCAs, and Vendors) will have the opportunity to be part of the UAT.

The Referentials sub-team is asking for coordination of the requested values per list. They do not want one-off requests for values until after go-live.

Leaders for gathering values and performing testing will be identified shortly.

Requests for updates to vocabularies must not be submitted until after the September 2016 go-live.

Organisations

The OMS system is targeted to go live in November 2016 with migrated MAH data from XEVMPD, MA Applicants, and Minimum Residual Level (MRL) Applicants.

Other organisations are targeted to be addressed in 2017.

UAT is targeted for July/August 2016 time frame.

Much like referentials, testers of the web interface and API will be needed

Products

A list of fields for Iteration 1 of Products was presented by the EMA.

The EU Network Data Board agreed to the list the day before the Task Force meeting.

A total of 20 data elements were removed or remodeled, and 5 data elements were added – leaving 79 as the total number of data elements defined for PMS Iteration 1.

Industry accepted the list with the caveat that there will be additional discussion about the effort required by Industry to attain some of the data.

The EMA is still expected to provide business cases expressing the value and use of the identified fields.

With the targeted implementation of the Falsified Medicines Directive (FMD) by February 2019, the Task Force is working on how IDMP Product data can be linked to FMD.

The possibility of using the GTIN is being discussed.

Work on Iteration 2 (Investigational Medicinal Products) will not be done in tandem with Iteration 1, but instead be a sequential process.

Timing for Iteration 2 was not specifically called out as yet.

Industry has requested that the EU Implementation Guide be written with a business process orientation and links to what is needed from a technical perspective, taking lessons learned from the XEVMPD Technical Specification.

It’s expected that the Guide will be holistic to include Referentials and Organisations.

Analysis is being done to determine the order in which to begin authoring the Guide based on the sections of the ISO Implementation Guide that are considered stable (i.e. Main body, Organisations, Pharmaceutical Product, and Clinical Particulars).

The EMA has identified resources to begin working on a Communication Strategy.

Industry will have representation on this team.

Details will be forthcoming.

The Global Substance Registration System (G-SRS/GInAS) is targeted to go live at the FDA in April 2016.

The EMA has agreed to provide their update coming out of the HMA and the Task Force meeting on the EMA IDMP/SPOR website by late February or early March 2016.

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